Senior Regulatory Affairs Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Santa Clara
Posted on: March 10, 2023

Job Description:

Responsibilities:

• 
  
• Develop strategies to ensure the company's production activities comply with government regulations
  
• Serve as a liaison between regulatory bodies and operating divisions of the company
  
• Prepare and submit applications and reports to applicable regulatory agencies
  
• Respond to requests for information from regulatory bodies
  
• Coordinate with operations department regarding production design and development to ensure compliance with regulations
  
• Assist with the development of standards for the company's operating and production procedures
  
• Maintain current knowledge of regulations applicable to the company
  
• Monitor regulatory affairs and the effect changes will have on company operations
  
• Develop and maintain professional relationships in federal, state, and local regulatory agencies
  
• Work closely with internal and external teams to ensure accurate implementation, compliance of designs
  
  Requirements:
  
  
  • 
    
  • Bachelors/Master's Degree in Life Sciences or related field
    
  • 5+ years relevant experience in medical devices, preferable premarket devices
    
  • Experience in large company and/or start-up environment
    
  • Extensive knowledge of applicable government regulations
    
  • Ability to inform and educate managers and department heads on regulations and policies that require compliance
    
  • Demonstrated in-depth knowledge of ISO standards and systems
    
  • Demonstrated experience in implementation of Quality systems: US FDA 21CFR 820 QSR, IVDR, European MDR/MDD
    
  • Experience with Japanese PDMA is preferred, but not required
    
  • Medical Writing experience is preferred, but not required
    
    

Keywords: Katalyst Healthcares & Life Sciences, Santa Clara , Senior Regulatory Affairs Specialist, Other , Santa Clara, California